Exercise Versus Niacin in Patients With Coronary Artery Disease (CAD) and Low High-Density Lipoproteins (HDL)

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators want to study the relative effects of physical exercise vs. extended-release niacin (lipid-lowering drug) in patients with coronary heart disease and low HDL cholesterol ("good cholesterol") on

• lipid profile

• endothelial function as measured by ultrasound

The endothelium is the inner part of the blood vessels. Impaired endothelial function is known to be associated with atherosclerosis which can ultimately lead to diseases such as stroke, heart attack and others. Endothelial function can be assessed non-invasively by ultrasound.

Both interventions mentioned above have been shown to have a beneficial effect on lipid profile and endothelial function. However, the relative effects are unclear.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leipzig
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• Coronary disease

• Low HDL cholesterol

• Age limits (see below)

Exclusion Criteria:

• Unstable angina oder MI within 3 months prior to inclusion

• CAD with indication for bypass surgery

• Left main disease ( > 25% stenosis diameter)

• Ejection fraction < 40%

• Higher degree heart valve disease

• Higher degree ventricular arrhythmias

• Type 1 Diabetes

• Severe disorders of lipoprotein metabolism (Low-density lipoprotein cholesterol (LDL)> 5.0 mmol/L)

• Severe liver disease

• Thyroid disease

• Alcohol or drug abuse

• Pregnancy

• Stroke or Transient Ischemic Attack (TIA) within 3 months prior to inclusion

• Allergy against niacin oder other ingredient of niaspan

• Participation in other clinical trial within 30 days prior to inclusion

• Acute gastric ulcer

• Arterial bleeding

• Uncontrolled severe arterial hypertension

• Treatment with lipid-lowering drug other than Hydroxy-Methylglutaryl Coenzyme A (HMG-CoA)-inhibitor within 3 months prior to inclusion